Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020597
Company: UPJOHN
Company: UPJOHN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| XALATAN | LATANOPROST | 0.005% | SOLUTION/DROPS;OPHTHALMIC | Prescription | AT | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/05/1996 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020597Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/19/2022 | SUPPL-54 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020597s054lbl.pdf | |
| 09/01/2020 | SUPPL-52 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020597s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020597Orig1s052ltr.pdf | |
| 04/10/2017 | SUPPL-51 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020597s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020597Orig1s051ltr.pdf | |
| 04/03/2014 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/25/2014 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020597s045s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020597Orig1s045,s048ltr.pdf | |
| 03/13/2013 | SUPPL-46 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020597s046lbl.pdf | |
| 11/25/2014 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020597s045s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020597Orig1s045,s048ltr.pdf | |
| 03/13/2012 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020597s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020597s044ltr.pdf | |
| 07/29/2010 | SUPPL-39 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 08/31/2010 | SUPPL-36 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020597s035s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020597s035,s036ltr.pdf | |
| 08/31/2010 | SUPPL-35 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020597s035s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020597s035,s036ltr.pdf | |
| 07/14/2003 | SUPPL-29 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20597scs029,slr028ltr.pdf |
| 07/14/2003 | SUPPL-28 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20597scs029,slr028ltr.pdf |
| 11/15/2002 | SUPPL-26 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020597Orig1s026Approv.pdf |
| 08/26/2002 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20597s25lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20597scp025ltr.pdf | |
| 06/21/2002 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/26/2001 | SUPPL-23 | Manufacturing (CMC)-Control |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20597s23lbl.pdf | |
| 05/14/2001 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/23/2001 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/08/2001 | SUPPL-19 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20597s19lbl.pdf | |
| 08/25/2000 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 12/11/2000 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/09/2000 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/26/2000 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 06/02/2000 | SUPPL-13 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020597Orig1s013Approv.pdf |
| 10/08/1999 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 01/24/2000 | SUPPL-11 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020597Orig1s011Approv.pdf |
| 12/20/2002 | SUPPL-10 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20597SE1-010_Xalatan_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20597se1-010ltr.pdf | |
| 07/16/1999 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 03/22/1999 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 11/01/1998 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/31/1998 | SUPPL-5 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020597Orig1s005Approv.pdf |
| 12/09/1998 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/23/1998 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/19/2022 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020597s054lbl.pdf | |
| 09/01/2020 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020597s052lbl.pdf | |
| 04/10/2017 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020597s051lbl.pdf | |
| 11/25/2014 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020597s045s048lbl.pdf | |
| 11/25/2014 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020597s045s048lbl.pdf | |
| 03/13/2013 | SUPPL-46 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020597s046lbl.pdf |
| 03/13/2012 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020597s044lbl.pdf | |
| 08/31/2010 | SUPPL-36 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020597s035s036lbl.pdf | |
| 08/31/2010 | SUPPL-35 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020597s035s036lbl.pdf | |
| 12/20/2002 | SUPPL-10 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20597SE1-010_Xalatan_lbl.pdf | |
| 08/26/2002 | SUPPL-25 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20597s25lbl.pdf | |
| 11/26/2001 | SUPPL-23 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20597s23lbl.pdf |
| 08/08/2001 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20597s19lbl.pdf |
XALATAN
SOLUTION/DROPS;OPHTHALMIC; 0.005%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LATANOPROST | LATANOPROST | 0.005% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 200925 | AMRING PHARMS |
| LATANOPROST | LATANOPROST | 0.005% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 201006 | BAUSCH AND LOMB |
| LATANOPROST | LATANOPROST | 0.005% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 202442 | FDC LTD |
| LATANOPROST | LATANOPROST | 0.005% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 218257 | GLAND |
| LATANOPROST | LATANOPROST | 0.005% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 220360 | MANKIND PHARMA |
| LATANOPROST | LATANOPROST | 0.005% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 219306 | MICRO LABS |
| LATANOPROST | LATANOPROST | 0.005% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 091449 | SANDOZ |
| LATANOPROST | LATANOPROST | 0.005% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 201786 | SOMERSET |
| XALATAN | LATANOPROST | 0.005% | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT | 020597 | UPJOHN |